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Mylabtwice Model 6200

FDA 510(k)EUDAMED

Class II (US FDA 510(k))

510(k) K100931

by Esaote S.p.A.

Identifiers

510(k) Number
K100931 FDA 510(k)
FDA Product Code
IYN FDA 510(k)

Classification

Device Class
Class II FDA 510(k)
Legislation / Framework
21 CFR Part 892.1550 FDA 510(k)
Regulation Number
892.1550 FDA 510(k)
Advisory Committee
Radiology FDA 510(k)
FDA Decision
SESE Substantially Equivalent FDA 510(k)

The Mylabtwice Model 6200 is a portable ultrasound imaging system designed for diagnostic radiology applications. It provides real-time visualization of internal body structures using high-frequency sound waves, enabling clinicians to assess organs, tissues, and vascular systems for diagnostic purposes.

This device is supplied as a reusable, non-sterile medical instrument intended for use in clinical settings such as hospitals, outpatient clinics, and emergency departments. It operates within standard MRI safety guidelines for non-MRI environments and requires proper maintenance and calibration as outlined in manufacturer instructions. Authorized for use in the United States under FDA 510(k) clearance (K100931) and compliant with the Medical Device Directive (MDD)

Frequently asked questions

Is the MYLABTWICE Model 6200 designed for single-use or can it be reused in a clinical setting?

The MYLABTWICE Model 6200 is explicitly described as a reusable medical instrument, not intended for single-use. Since it is non-sterile, it must undergo proper cleaning, maintenance, and calibration between uses as outlined in the manufacturer’s instructions to ensure safe and accurate operation in clinical settings like hospitals or outpatient clinics.

What types of clinical environments is this ultrasound system intended for, and how does its portability factor into its use?

The MYLABTWICE Model 6200 is designed for diagnostic radiology applications in flexible clinical environments such as hospitals, outpatient clinics, and emergency departments. Its portable nature allows for real-time imaging of internal structures—such as organs, tissues, and vascular systems—without requiring the patient to be moved to a fixed ultrasound machine, making it ideal for bedside or mobile diagnostic assessments.

How does the device comply with safety standards, particularly in relation to MRI environments?

The MYLABTWICE Model 6200 is not MRI-compatible for use inside MRI environments, but it adheres to standard MRI safety guidelines for non-MRI environments. This means it can be safely used in areas where MRI machines are present, provided it is not brought into the MRI scanning room itself. Always follow the manufacturer’s guidelines for proper placement and maintenance to ensure safety.

What regulatory pathways has this device undergone, and what does that mean for its use in the U.S.?

The MYLABTWICE Model 6200 has undergone FDA 510(k) clearance (K100931) and complies with the Medical Device Directive (MDD) in Europe. In the U.S., this clearance indicates the device is deemed substantially equivalent to a legally marketed predecessor, meaning it meets FDA standards for safety and effectiveness as determined by the Radiology (RA) advisory committee. Clinicians can rely on this approval for its intended diagnostic radiology use.

This description and any FAQs above were generated automatically from registry data and have not been verified by the manufacturer or by deviCERTS. Always check the official registry entry and the manufacturer's instructions for use before relying on them.

Authorization Coverage (2 countries)

Regulatory Authorizations

European Union Active

MDD

United States Active

FDA_510K

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Manufacturer

Manufacturer
Esaote S.p.A.
FDA Applicant
Esaote, S.p.A.

Sources (2)

  • FDA 510(k) K100931 24 fields · synced Sep 18, 2026
  • EUDAMED 1 fields · synced May 19, 2026